Device for inserting a flexible intraocular lens

ABSTRACT

This invention is a device for inserting a flexible intraocular lens ( 12 ) into an eye comprising a tubular member ( 16 ) and a plunger ( 18 ). The tubular member includes a staging area ( 45 ), a lumen, and an open distal end ( 95 ). The staging area support unstressed state prior to engagement by the plunger. In the unstressed state, the optic ( 48 ) of the lens is suspended in a pocket to avoid substantial contact with interior portions of the tubular member. The plunger includes a slot ( 132 ) in its distal tip fo receiving and gripping the lens. With this construction, the lens can be inserted into the eye in one continuous motion. Further, the plunger holds the lens when the lens is moved out of the tubular member.

FIELD OF THE INVENTION

[0001] The present invention pertains to a device for inserting aflexible intraocular lens (IOL) into the eye of a patient.

BACKGROUND OF THE INVENTION

[0002] The natural crystalline lens of the eye plays a primary role infocusing light onto the retina for proper vision. However, the lens canbecome damaged due to injury or become cloudy because of the agingprocess or disease and form a cataract. To restore vision to the eye,the natural lens must be surgically removed and an artificial lensimplanted as a replacement.

[0003] Many surgical procedures have been developed for removing thenatural lens. As an example, phacoemulsification is one such processwhich has gained wide popularity. According to this procedure, a slenderimplement is inserted through an incision made in the eye and into thenatural lens. The implement produces ultrasonic vibrations andemulsifies the lens. The emulsified portions of the lens are thenaspirated out of the eye through a passage provided in the implement. Asopposed to other procedures, this lens extraction method requires thesurgeon to make only a narrow incision in the eye. In general, the useof a small incision can lessen the trauma and complications experiencedduring the surgery and postoperatively.

[0004] A flexible IOL comprises a central optic portion which focuseslight on the retina and at least one outwardly extending haptic. Hapticscan have a variety of different configurations, but most commonly areeither a plate-like extension of the optic or loop shaped. In any event,the haptics extend outwardly to position the optic of the lens inalignment with the pupil. Flexible IOLs are particularly suited forinsertion in the eye following a phacoemulsification lens extractionprocedure. Whereas placement of a hard, non-foldable IOL would requirewidening of the small phacoemulsification incision, a flexible IOL canbe compressed or folded for passage through the narrow incision in theeye. Once the lens is passed through the incision and released into theeye, it will expand to its original shape and size.

[0005] A number of different devices have been developed to implant aflexible IOL into an eye. See, for example, U.S. Pat. Nos. 4,573,998 toMazzocco, 4,681,102 to Bartell, 4,919,130 to Stoy et al., and 5,275,604to Rheinish et al. In general, these devices function to pass acompressed lens through the narrow incision made in the eye. Thesedevices, however, require undue manipulation of the lens, include amultiplicity of parts, and/or fail to provide ample control of the lensas it enters the eye.

SUMMARY OF THE INVENTION

[0006] The present invention is a device which enables flexible IOLs tobe easily folded, compressed and inserted through an incision in theeye. In general, the insertion device comprises a tubular member forreceiving the lens and a plunger for pushing the lens through thetubular member and into the eye. As the lens is pushed through thepassage it is compressed into a smaller configuration. The constructionof the present invention ensures an easy, sure and consistentcompression of the lens.

[0007] According to one aspect of the invention, the tubular memberincludes a staging area for holding the lens in an unstressed condition.The lens is preferably held in a suspended position by its haptics sothat the optic remains substantially free of contact with the interiorof the tubular member. In this manner, the device can be used as thelens package, and the device can be shipped and stored with the lensalready in place and ready for use. As a result, unnecessarymanipulation of the lens is avoided. According to another aspect of theinvention, the plunger tip is provided with a structure which holds thelens to the plunger when the lens is pushed out of the tubular member.The distal tip of the plunger is preferably bifurcated to define a slotfor partially receiving and gripping the lens. With this construction,the plunger is able to hold the lens when the lens exits the tubularmember and expands into the eye. Holding the lens in this manner easesplacement of the lens in the eye and alleviates the risks associatedwith uncontrolled unfolding of the lens or uncontrolled expulsion of thelens from the inserter into the eye.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]FIG. 1 is a perspective view of an insertion device in accordancewith a preferred embodiment of the present invention.

[0009]FIG. 2 is a side elevational view of the plunger of the insertiondevice.

[0010]FIG. 3 is a top plan view of the plunger.

[0011]FIG. 4 is a cross sectional view taken along line 4-4 in FIG. 3.

[0012]FIG. 5 is a partial top plan view of the tubular unit of theinsertion device, including the staging area, with the cover removed andoverturned, and the cannula omitted.

[0013]FIG. 6 is a cross sectional view taken along line 6-6 in FIG. 5with the cover placed onto the shelf segment.

[0014]FIG. 7 is a cross sectional view taken along line 7-7 in FIG. 5with the cover placed onto the shelf segment.

[0015]FIG. 8 is a cross sectional view taken along line 8-8 in FIG. 5with the cover placed onto the shelf segment.

[0016]FIG. 9 is a cross sectional view taken along line 9-9 in FIG. 5with the cover placed onto the shelf segment.

[0017]FIG. 10 is a cross sectional view taken along line 10-10 in FIG. 5with the cover placed onto the shelf segment.

[0018]FIG. 11 is a cross sectional view taken along line 11-11 in FIG. 5with the cover placed onto the shelf segment.

[0019]FIG. 12 is a cross sectional view along line 12-12 in FIG. 13.

[0020]FIG. 13 is a partial cross sectional view taken along line 13-13in FIG. 1, with an IOL in the staging area.

[0021]FIG. 14 is an exploded view of FIG. 13.

[0022]FIG. 15 is a partial top plan view of the tubular unit of theinsertion device with an IOL in the staging area and with the cover andcannula omitted.

[0023]FIG. 16 is side elevational view of the distal tip of the plunger.

[0024]FIG. 17 is a front view of the distal end of the plunger.

[0025]FIG. 18 is a top plan view of the distal end of the plunger.

[0026] FIGS. 19-23 are each a schematic, partial cross sectional viewstaken along line 19-19 in FIG. 1, illustrating the movement of theplunger during insertion of the IOL into an eye.

[0027]FIG. 24 is an enlarged top plan view of the distal tip of theplunger holding an IOL.

[0028]FIG. 25 is a front end view of the insertion device with theplunger extended to the distal end of the cannula.

[0029]FIG. 26 is a cross sectional view of an eye illustrating theinsertion and placement of an IOL.

[0030]FIG. 27 is a perspective view of an alternative construction ofthe distal end of the cannula.

[0031]FIG. 28 is a perspective view of a second alternative constructionof the distal end of the cannula.

[0032]FIG. 29 is a perspective view of a third alternative constructionof the distal end of the cannula.

[0033]FIG. 30 is a side elevational view of a fourth alternativeconstruction of the distal end of the cannula.

[0034]FIG. 31 is a front elevational view of the fourth alternativeconstruction of the distal end of the cannula.

[0035]FIG. 32 is a perspective view of an alternative embodiment of thecannula.

[0036]FIG. 33 is a perspective view of another alternative embodiment ofthe cannula.

[0037]FIG. 34 is a partial, longitudinal cross sectional view of analternative embodiment of the tubular unit with the cover open and thecannula removed.

[0038]FIG. 35 is a cross sectional view taken along line 35-35 in FIG.34, without the cover.

[0039]FIG. 36 is a plan view of the inside of the cover of thealternative tubular unit embodiment of FIG. 34.

[0040]FIG. 37 is a plan view of the inside of the shelf segment of thealternative tubular unit embodiment of FIG. 34.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] The present invention pertains to a device 10 (FIG. 1) forinserting a flexible IOL 12 into an eye 14 of a patient (FIG. 26). Thedevice comprises an outer tubular unit 16 and an inner plunger 18. Inone embodiment, tubular unit 16 is formed by a base member 20, a cover21 and a cannula 22 which are coupled together (FIGS. 1, 13 and 14). Thecomponents of device 10 may be composed of a plastic or metal material.For example, the components can be formed of polycarbonate orpolypropylene. The plunger 18 and cannula 22 are preferably made ofpolypropylene. Nevertheless, a wide array of materials could be used.

[0042] Base member 20 is an elongate tubular member defining an innerpassage 24 which is provided with a relatively large opening at proximalend 26 and an opening 27 of reduced size near, but spaced from, distalend 28 (FIGS. 1, 5, 13 and 14). A forwardly extending shelf segment 29projects beyond opening 27 (FIGS. 5, 13 and 14). Base member 20preferably has generally oval cross sectional configuration, althoughother shapes could be used.

[0043] The inner passage 24 of base member 20 is adapted to movablyreceive therein plunger 18. A longitudinal groove 34 is preferentiallypositioned along one of the side walls 32 defining inner passage 24(FIG. 13). Groove 34 cooperates with an extending flange 35 projectinglaterally from plunger 18 to ensure that the plunger is properlyoriented when fed into base member 20. Nevertheless, the grooveconstruction could be replaced with a different structure for ensuringproper placement, such as forming at least a portion of inner passage 24and plunger 18 with a D-shaped configuration. Near distal end 28, basemember 20 forms a narrowed neck 39. Neck 39 defines distal opening 27through which a portion of the plunger is passed to engage lens 12.Converging guideways 41 are positioned along opposite interior sides ofpassage 24 leading up to neck 39 FIGS. 5, 13 and 14). Guideways 41function to ease the passage of the plunger through neck 39 and over theshelf segment 29 for engagement with lens 12.

[0044] Shelf segment 29 is formed as an extension of roughly one half ofthe tubular base member 20. Shelf segment 29 cooperates with cover 21 todefine a staging area compartment 45 for holding lens 12 (FIGS. 5-11 and13-14). Lens 12 preferably has a central optic and a pair of adjacentweb or plate haptics 49 a, 49 b (FIGS. 14 and 24). Nevertheless, otherlens constructions, such as a lens with loop haptics, could also beused. The interior side of shelf segment 29 is formed in part by a pairof ledges 51 a, 51 b adjacent neck 39, a pair of recessed central flats52 a, 52 b, and a pair of ramps 53 a, 53 b spaced forwardly of flats 52a, 52 b (FIGS. 5-11 and 13-14). Ledges 51 a, 51 b and ramps 53 a, 53 bare each formed with top surfaces 54 a, 54 b, 55 a, 55 b to engage andsupport the haptics 49 a, 49 b of lens 12 in an initial unstressedposition. Ramps 53 a, 53 b further include sloped surfaces 59 a, 59 binclined to flats 52 a, 52 b. Flats 52 a, 52 b are recessed relative totop surfaces 54 a, 54 b, 55 a, 55 b to define a pocket 60 into which isreceived optic 48.

[0045] Cover 21 lies against shelf segment 29 to form staging areacompartment 45 and enclose lens 12 in its initial unstressed position(FIG. 13). Cover 21 includes on its interior side recessed sections 61a, 61 b, the central portions of which lie opposed to the proximal halfof flats 52 a, 52 b. A pair of adjacent plateau segments 63 a, 63 b lieopposed to ledges 51 a, 51 b to define a gap 65 adapted to matinglyreceive and hold the proximal haptic 49 a. Haptic 49 a is looselyreceived in gap 65 so that it can be easily pushed out of staging area45 during the insertion process. Ledges 51 a, 51 b, plateau segments 63a, 63 b, and ramps 53 a, 53 b collectively support lens 12 by haptics 49a, 49 b. In this initial position, optic 48 is held in suspension inpocket 60 so that the optic avoids contact with the interior walls ofthe staging area compartment 45.

[0046] The lens 12 can be installed in compartment 45 at a manufacturingplant and shipped to is the user in device 10 with or without cannula 22assembled in place. In this manner, device 10 can conveniently servealso as a lens package. Since lens 12 is supported in a generallysuspended and unstressed state, the lens can be stored for a substantiallength of time, perhaps as long as 10 years. Although the cover could befixed to base member 20, it is designed for removal to enable inspectionof the lens prior to its implantation in the eye. As shown in FIG. 14,cover 21 can be separable from base member 20, and secured in place by asnap fit, tape or other securing means. Nevertheless, the cover may behinged to cannula 22, shelf segment 29, or neck 39.

[0047] Cover 21 includes projections 67 a, 67 b which mate withdepressions 68 a, 68 b formed in shelf segment 29. In addition, shelfsegment 29 includes proximal outer walls 70 a, 70 b and distal outerwalls 72 a, 72 b. Proximal walls 70 a, 70 b abut the outer portions ofrecessed sections 61 a, 61 b. Distal walls 72 a, 72 b likewise abutwalls 73 a, 73 b of cover 21. Distal walls 72 a, 72 b are preferablyrecessed relative to proximal walls 70 a, 70 b to enhance the mating fitof cover 21. During shipping of the device, the cover may be held closedby cannula 22, tape and/or other means to avoid inadvertent release ofthe lens.

[0048] Troughs 75 a, 75 b are formed in shelf segment 29 by extendingthe inner side wall surface 78 of compartment 45 downwardly between theouter distal sides of flats 52 a, 52 b and distal walls 72 a, 72 b.Troughs 75 a, 75 b are provided to receive the opposite sides of lens 12as they are folded or curled along inner side wall surface 78. In thepreferred embodiment, the troughs are deeper than flats 52 a, 52 b.

[0049] Cover 21 further-includes a central, generally planar surface 88inclined to extend away from shelf segment 29. A conically shapedportion 91 generally surrounding inclined surface 88 lies opposed toramps 53 a, 53 b. These surfaces 88, 91 in cooperation with ramps 53 a,53 b initiate the desired folding of the lens to its compressed state.

[0050] Cannula 22 is an elongate tubular member with an open proximalend 93 and an opposite open distal end 95 (FIGS. 1 and 12-14). Cannula22 is preferably subdivided into three graduated sections 97-99. Theproximal section 97 has a generally rectangular configuration anddefines an inner cavity 101 sized to matingly receive the assembledshelf segment 29 and cover 21. Section 97 extends from distal end 28 toneck 39 of base member 20 and functions to hold cover 21 against shelfsegment 29. An axial channel 102 is defined along one wall of cavity 101to matingly receive ridge 103 extending up from cover 21. A hole 10defined at the proximal end 93 of cannula 22 cooperates with a biasedlock 106 on base member 20 to secure the cannula in place.

[0051] The medial section 98 of cannula 22 is significantly smaller thanproximal section 97 so that a rim 110 is defined therebetween. Rim 110acts as a shoulder in abutment with the aligned distal ends 28, 111 ofbase member 20 and cover 21. The inner wall of medial section 98converges to define a funnel shaped passage 112. The funnel portion 112preferably has an oval cross section, although other shapes could beused. This funnel section causes the lens to become substantially curledand compressed for entry into the eye.

[0052] The final, distal section 99 of cannula 22 is a long, narrow tubewhich defines an inner lumen 114. Distal section 99 is to be insertedthrough the narrow incision made in the eye. As with medial section 98,distal section 99 and lumen 114 preferably have an oval cross sectionalshape. Of course, other shapes could be utilized if desired. Tofacilitate manufacturing and further compression of lens 12, lumen 114is formed to taper slightly as it extends forward. Distal end 95 ofcannula 22 is beveled to ease the insertion of the cannula into theincision and to assist in facilitating a gradual expansion of the lensas it exits from lumen 114.

[0053] The distal section of the cannula may be provided with a widevariety of cross section configurations. As examples only, the cannulamay be shaped with a clover-type tip 22A, a collapsible bag type tip22B, or a wave-type tip 22C (FIGS. 27-29). These configured tips enhancethe strength of the tip and thus permit a narrower construction to beused. The cannula tip may also be formed with a collet-like construction22D. In this embodiment, the tip includes four separable leaves 23 whichare expanded as the lens is pushed into the eye. The leaves 23 arebiased to naturally close after the lens is placed into the eye and theplunger retracted.

[0054] In the preferred embodiment, cover 221 is hinged to base member220 of tubular unit 216 (FIGS. 34-37). The inside configuration of cover221 is essentially the same as the inside configuration of cover 21,except that projections 267 are interconnected with plateau segments 263by segments 264. Similarly, the inside configuration of shelf segment229 is essentially the same as the inside configuration of shelf segment29. As can be seen in FIG. 37, shelf segment 229 includes acorresponding interconnection of depressions 26 with ledges 251. Also,the central channel 224 of shelf segment 229, which accommodates passageof the plunger, is enlarged across its middle section. Thesemodifications do not affect the operation of compressing and insertingthe lens into an eye.

[0055] Also, as an optional feature, a hole 246 may be provided throughshelf segment 229. The hole can be used to insert a viscoelasticmaterial in embodiments wherein the cover is fixed to the shelf segmentor otherwise not opened by the surgeon.

[0056] Cover 221 further includes a pair of rearwardly extending arms265, which are provided with knobs 266 on their free ends. Arms 265 areprovided to pivotally connect the cover to neck portion 239.Specifically, neck portion 239 includes a pair of sockets 242. Sockets242 are formed to include substantially square shaped openings 243(although other shapes could also be used) for receiving knobs 266, andchannel portions 244 for receiving arms 265 when cover 221 is moved toits closed position (not shown). Recesses 245 are formed on the outsidewalls of openings 243 (FIG. 35) to receive the outward projection ofknobs 266. Receipt of knobs 266 in recesses 245 functions to retain thecover 221 to base member 220.

[0057] In an alternative embodiment, cannula 160 includes a cover 162hinged for movement between an open position and a closed position (FIG.32). Cannula 160 has essentially the same construction as cannula 22,except for the incorporation of cover 162 in proximal section 164. Cover162 has substantially the same construction as cover 21, including thesame internal configuration for supporting and compressing the lens.

[0058] Proximal section 164 of cannula 160 comprises a base 166 and acover 162. The base includes a bottom wall 168 and a pair of side walls170 which extend upward only as high as shelf segment 29. The internalsurfaces of bottom wall 168 and side walls 170 are shaped to matinglyreceive the external surface of shelf segment 29. A pair of upstandingflanges 172 are provided at proximal end 174 of base 166 to engage neck39 and provide ample support for the cannula. A hole 176 is provided tocooperate with a protrusion (not shown) on shelf segment 29 in lockingthe cannula to the base member 20.

[0059] Cover 162 is movably connected to base 166 by a living hinge 178,although other hinge constructions could also be used. The cover ispivotally movable to an open position to permit inspection of the lens,and to a closed position for inserting the lens into a patient's eye.The lower edges of side walls 180 of the cover are formed to snap into alocking engagement with base 166 by any conventional construction (notshown); nevertheless, other fastening arrangements could be used. Theinternal configuration of cover 162 aligns with the internalconfiguration of shelf segment 29 in the same way as cover 21. Cover 162further includes a proximal tab 182 which projects between flanges 172to engage locking protrusion 106 in hole 184.

[0060] As an alternative construction, side walls 170 a of cannula 160 aextend the entire depth of proximal section 164 a, and cover 162 a isprovided with a flattened construction (FIG. 33). The internal side ofcover 162 a has the same configuration and relative positioning to shelfsegment 29 as does the above-described cover 21. The edges 180 a ofcover 162 a are preferably constructed to snap into locking engagementwith edges 181 a of side walls 170 a. Nonetheless, other fasteningarrangements could be used.

[0061] Preferably, cannula 162, 162 a is composed of a polypropylene orother thermoplastic material. A disposable cover (not shown), can beused to ship and store the IOL in device 10. The disposable coverpreferably has the same general size and shape as cover 162, 162 a toenable it to snap into engagement with base 166, 166 a. The disposablecover can have a wide variety of internal constructions so long as theIOL is adequately supported (as described above with respect to theother covers) and protected.

[0062] Plunger 18 is an elongate member which is adapted to move throughthe inner passage 115 defined by tubular unit 16 (FIGS. 1 and 13). Theplunger comprises a main body 116 preferably shaped with a cross shapedcross section (FIGS. 2-3). As discussed above, one flange 35 of the bodyis received into groove 34 to ensure proper placement of the plunger. Aflat thumb pad 119 is provided on the proximal end of body 116 formanual operation of the device. Other constructions, however, may beprovided to effect advancement of plunger 18 through tubular unit 16.The forward end of body 116 includes a pair of spaced apart O-rings 120a, 120 b. The O-rings provide a level of resistance to enable a morecontrolled manual operation of the plunger. The O-rings further help toprevent the plunger from inadvertent movement when the surgeonmanipulates device 10 during the surgical procedure. Otherconstructions, such as friction fit flanges, could be used in place ofthe O-ring.

[0063] A slender rod 122 projects forwardly beyond the main body 116 ofplunger 18. The rod is intended to pass through staging area 45, funnel112 and lumen 114. In order to provide sufficient clearance for rod 122,shelf segment 29 defines a channel 124 and cover 21 includes a relief125 (FIGS. 5-11 and 13-14). Relief 125 only extends partway across cover21 because surface 88 diverges away from the interior side of shelfsegment 29 and thus provides sufficient clearance for rod 122. While rod122 could have a wide range of shapes, it preferably has a circular or aslight ellipsoid shape adapted to pass through the distal end 95 ofcannula 22 (FIG. 25).

[0064] The distal tip 128 of rod 122 is preferably bifurcated to definea pair of prongs 131 a, 131 b separated by a slot 132 (FIGS. 2-3, 16-18,24 and 25). The slot is shaped to receive and hold proximal haptic 49 aand optic 48 of lens 12. The ends 135 a, 135 b of prongs 131 a, 131 bare chamfered to form a pair of walls 137 a, 137 b which collectivelyform a generally V-shaped configuration. Depending on the sturdiness ofthe proximal haptic, walls 137 a, 137 b may or may not engage theproximal end of the optic 48. Prongs 131 a, 131 b are preferablyidentical to one another. Nevertheless, one prong 131 a can be madenarrower than the other prong 131 b to allow extra space for the lens 12to curl and compress during its passage through lumen 114 and into thepatient's eye. Under ordinary circumstances, however, the extra space isnot needed.

[0065] The distal tip of plunger 18 may alternatively be formed withother structural configurations which would hold the lens when the lensis pushed out of the cannula. For example, when implanting an IOL withloop shaped haptics, the plunger may be formed with a closed verticalslot (not shown) along the top of rod 122 in lieu of the open horizontalslot 132. In this arrangement, the lens would be positioned in stagingarea 45 with the haptics extending from points along the sides of thetubular unit. The haptic, which curls rearwardly would be inserted intothe vertical slot when the lens is mounted in the staging area. To avoidinadvertent release of the haptic during shipping and storage, theplunger could be secured in a fixed position through the use of a latch,tape, or other securing means. In any event, the plunger would engagethe optic portion of the lens with its distal tip, formed for examplewith only inclined surfaces like 137 a, 137 b. When the lens isinitially extended beyond cannula 22, the noted haptic would remainentrapped in the slot which would not yet be exposed outside of cannula22. When release of the lens is desired, the plunger can be pushedslightly farther to expose the vertical slot and free the trappedhaptic. The plunger can then be retracted into the tubular unit 16 whilethe lens remains in the eye.

[0066] In one embodiment, a pair of resilient spring elements 140 a, 140b extends laterally from rod 122 near the rod's proximal end (FIGS.2-3). The spring elements function to press against guideways 41 whenthe free end 128 of rod 122 extends beyond cannula 22. This engagementwith guideways 41 forces spring elements 140 a, 140 b to be pushedbackward, and thereby create a biasing force to pull the plungerrearward into tubular unit 16. In the preferred construction, the springelements (not shown) would extend forwardly, generally parallel with rod122, from the front end of the main body. In this arrangement, thespring elements would be designed to curl inward upon engagement withguideways 141. Additionally, a coil spring (not shown) may be securedaround the plunger/rod to provide the desired biasing force. Of course,other spring arrangements could also be used. The spring may also beomitted and the plunger retracted manually by the surgeon.

[0067] Once the lens has been inspected, device 10 can be assembled. Aviscoelastic material, typically used for such surgical procedures, isplaced in the cannula 22, typically prior to attachment of the cannula22 to the assembly, as a lubricant for the insertion process. Oncedevice 10 is assembled, the surgeon inserts the distal end of cannula 22into the incision 142 in the eye 14. The surgeon then grasps lateralflanges 141 and pushes on pad 119 to move plunger 18 in a continuousforward motion. (FIG. 1). The continuous movement of rod 122 throughtubular unit 16 engages lens 12 through its distal end 128 (FIG. 24).the proximal haptic 49 a and possibly a portion of optic 48 are receivedinto and held by slot 132, between walls 137 a, 137 b. The lens is thenpushed forwardly by plunger 18 so that the distal side of optic 48 isshifted transversely toward cover 21 by sloped surfaces 59 a, 59 b oframps 53 a, 53 b; that is, sloped surfaces 59 a, 59 b guide the centralportion of optic 48 away from flats 52 a, 52 b (FIGS. 19 and 20).Inclined surface 88 and conical surface 91 provide ample clearance forthis motion of the lens. As the center of the lens is shifted to moveover ramps 53 a, 53 b, the sides of the lens are forced generally in thedirection opposite to the ramps, by the inner wall surface 78 of cover21. Specifically, the conical surface 91 in cover 21 causes lens 12 tocurl into troughs 75 a, 75 b. Continued advancement of lens 12 throughthe tapering passage of tubular unit 16 causes continued curling andcompression of the lens.

[0068] The lens continues its forward motion until plunger 18 pusheslens 12 beyond cannula 22. In the preferred construction, plunger 18 ispushed manually forward in a controlled manner, although other means,such as an electric motor or pneumatic drive, may be used.

[0069] The leading haptic 49 b is fed into the distal cul-de-sac 152 ofthe capsular bag 154. When lens 12 exits from cannula 22, it expands toits full unstressed state (FIGS. 22, 24 and 26). The lens, however,remains held in the slot 132 of plunger 18. Retention of the lens by theplunger reduces the risk of the lens expelling in an uncontrolled mannerfrom the cannula and damaging the interior of the eye. Retaining thelens with the plunger also provides increased control in placing thelens in the eye. To release the lens, the plunger is retracted intotubular unit 16 so that the lens is pushed from slot 132 by distal end95 of cannula 22 (FIG. 23). The retraction of plunger 18 is preferablyperformed automatically by biased spring elements 140 a, 140 b whenpressure is released from thumb pad 119. A further implement, or perhapsdevice 10 itself, will typically be required to properly position theproximal haptic 49 a into capsular bag 154.

[0070] The above-discussion concerns the preferred embodiments of thepresent invention. Various other embodiments as well as many changes andalterations may be made without departing from the spirit and broaderaspects of the invention as described in the claims. For example,although the preferred embodiments concern the insertion of a flexibleIOL into the eye, the invention is not so limited. The teachings of thepresent invention are applicable to the insertion of flexible membranesgenerally, including synthetic membranes, biopolymer membranes, andnatural body tissues.

1. A device for inserting a flexible membrane into an eye, said devicecomprising: a tubular member including a passage for receiving aflexible membrane, said passage having an open distal end for insertingthe flexible membrane into an eye; and a plunger being movably receivedwithin said passage of said tubular member for moving the flexiblemembrane out through said open distal end of said tubular member andinto the eye, said plunger including a distal tip configured to holdsaid flexible membrane to said plunger after the flexible membrane ispushed entirely out of said passage.
 2. A device in accordance withclaim 1 in which said flexible membrane is a flexible intraocular lenshaving an optic and at least one haptic, and said plunger distal tipdefines a slot for receiving and holding at least one haptic of the lensor the optic.
 3. A device in accordance with claim 2 in which said slotin said plunger includes a proximal portion defined by a pair ofgenerally parallel side walls for engaging a haptic of the lens and adistal portion defined by a pair of diverging sidewalls for engaging theoptic of the lens.
 4. A device in accordance with claim 1 in which saidplunger further includes at least one spring element for retracting saidplunger into said passage of said tubular member.
 5. A device inaccordance with claim 4 in which said spring element includes a pair ofresilient projections which engage a wall surface in said passage toapply a biasing force to retract said plunger when said plunger extendsoutside of said distal end of said passage.
 6. A device in accordancewith claim 1 in which said tubular member further includes a stagingarea along said passage for supporting the flexible membrane in anunstressed state prior to being engaged by said plunger.
 7. A device inaccordance with claim 6 in which said flexible membrane is a flexibleintraocular lens having an optic and at least one haptic, and saidstaging area includes supporting surfaces for supporting at least onehaptic of the lens so that the optic of the lens is suspended to avoidany substantial contact with interior portions of said tubular member insaid unstressed state.
 8. A device in accordance with claim 7 in whichsaid supporting surfaces includes a pair of distal supports and an openspace adjacent each of said distal supports, said open spaces beingadapted to receive side portions of said lens as the lens is compressed.9. A device in accordance with claim 6 in which said passage of saidtubular member tapers as it extends from said staging area to saiddistal end.
 10. A device in accordance with claim 6 in which saidstaging area includes a cover which can be opened to expose the flexiblemembrane for inspection.
 11. A device in accordance with claim 10 inwhich said tubular member further includes a separate cannula elementwhich is received over said cover to hold said cover in a closedposition.
 12. A device in accordance with claim 1 in which said tubularmember includes supporting surfaces for a cover which can be opened toexpose the flexible membrane for inspection.
 13. A device in accordancewith claim 1, in which said tubular member includes a cannula and a basemember, wherein said base member includes a stage for supporting theflexible membrane, and said cannula includes said open distal end and acover which overlies said stage, wherein said cover is hingedlyconnected for movement between an open position and a closed position.14. A device in accordance with claim 13, which further includes anauxiliary cover wherein said auxiliary cover is used for storing theflexible membrane in said device, and said cannula cover is used toinsert the flexible membrane into an eye.
 15. A device for inserting aflexible intraocular lens having an optic and at least one haptic intoan eye, said device comprising: a tubular member including a passage forreceiving a lens, said passage having an open distal end for insertingthe lens into an eye and a staging area for supporting the lens in anunstressed state, said staging area including supporting surfaces forsupporting at least one haptic of the lens so that the optic of the lensis suspended to avoid any substantial contact with interior portions ofsaid tubular member in said unstressed state; and a plunger beingmovably received within said passage of said tubular member for movingthe lens out through said open distal end of said tubular member andinto the eye.
 16. A device in accordance with claim 15 in which saidsupporting surfaces include a pair of distal supports and an open spaceadjacent each of said distal supports, said open spaces being adapted toreceive side portions of said lens as the lens is compressed.
 17. Adevice in accordance with claim 15 in which said passage of said tubularmember tapers as it extends from said staging area to said distal end.18. A device in accordance with claim 15 in which said tubular memberincludes a cover which can be opened to expose the lens for inspection.19. A device in accordance with claim 18 in which said tubular memberfurther includes a separate cannula element which is received over saidcover to hold said cover in a closed position.
 20. A device inaccordance with claim 18, which further includes a separate cannulaelement that includes said open distal end and said cover, wherein saidcover is hingedly connected for movement between an open position and aclosed position.
 21. A device in accordance with claim 20, which furtherincludes an auxiliary cover wherein said auxiliary cover is used forstoring the flexible membrane in said device, and said cannula elementcover is used to insert the flexible membrane into an eye.
 22. A devicein accordance with claim 15 in which said plunger includes a distal tipprovided with means for holding the lens outside of said passage.
 23. Adevice in accordance with claim 22 in which said plunger furtherincludes a spring element for retracting said distal tip of said plungerinto said passage of said tubular member.
 24. A device for inserting aflexible membrane into an eye, said device comprising: a tubular memberdefining a path along which a flexible member is moved for insertioninto an eye, said path extending through a staging area, a lumen and anopen distal end, said staging area including a pocket for receiving theflexible membrane, a pair of upstanding members positioned at a forwardside of said pocket for shifting a central portion of the flexiblemembrane transversely away from a side of said tubular member as theflexible membrane is moved along said path, and an open space adjacenteach of said upstanding members into which side portions of the flexiblemembrane are folded as the flexible membrane is moved along said path;and a plunger being movably received within said tubular member formoving the flexible membrane along said path and into the eye.
 25. Adevice in accordance with claim 24 in which at least a portion of saidlumen tapers as it extends toward said distal end to compress saidflexible membrane to a smaller configuration.
 26. A device in accordancewith claim 24 in which said flexible membrane is an intraocular lenshaving an optic and at least one haptic, and said staging area furtherincludes means adjacent to a rearward portion of said pocket forsupporting a haptic of the lens so that the optic of the lens issuspended in said pocket to avoid any substantial contact with interiorportions of said staging area in said unstressed state.
 27. A device inaccordance with claim 24 in which said staging area includes a coverwhich can be opened to expose the flexible membrane in said unstressedstate for inspection.
 28. A device in accordance with claim 27 in whichsaid tubular member further includes a separate cannula element which isreceived over said cover to hold said cover in a closed position.
 29. Adevice in accordance with claim 27, which further includes a separatecannula element that includes said open distal end and said cover,wherein said cover is hingedly connected for movement between an openposition and a closed position.
 30. A device in accordance with claim29, which further includes an auxiliary cover wherein said auxiliarycover is used for storing the flexible membrane in said device, and saidcannula element cover is used to insert the flexible membrane into aneye.
 31. A device in accordance with claim 24 in which said plungerincludes means for holding said flexible membrane outside of saidtubular member.
 32. A device in accordance with claim 31 in which saidplunger includes a distal tip and said holding means is comprised of aslot formed in said distal tip.
 33. A device in accordance with claim 31in which said plunger further includes a spring element for retractingsaid plunger into said passage of said tubular member.
 34. A device forinserting a flexible membrane into an eye comprising: a tubular memberincluding a base member and a cannula element, said base member and saidcannula element collectively defining a passage for receiving a flexiblemembrane, said passage having an open distal end in said cannula elementfor inserting the flexible membrane into an eye, said base member havinga stage for supporting the flexible membrane in an unstressed state, andsaid cannula having a cover pivotable between an open position to permitaccess to the flexible membrane and a closed position to overlie saidstage for insertion of the flexible membrane into an eye; and a plungerbeing movably received within said tubular member for moving theflexible membrane along said passage and into an eye.
 35. A device inaccordance with claim 34, which further includes an auxiliary coverwherein said auxiliary cover is used for storing the flexible membranein said device, and said cannula element cover is used to insert theflexible membrane into an eye.
 36. A method of implanting a flexibleintraocular lens having an optic and at least one haptic into an eye,said method comprising inserting a distal portion of said tubular memberthrough an incision in an eye, holding a lens in said tubular member,engaging and holding said lens with a distal tip of a plunger, movingsaid lens along a path defined in said tubular member, folding said lensas it moves along said path so that the lens is compressed to a smallersize and moving said lens out of said tubular member and into the eye.37. A method in accordance with claim 36 in which said moving of thelens through said tubular member and into the eye is performed in onecontinuous motion after the tubular member is inserted through anincision in the eye.
 38. A method in accordance with claim 36 furthercomprising the steps of holding said lens to said distal tip of saidplunger when the lens is moved out of said tubular member, and releasingsaid lens from said plunger.
 39. A method in accordance with claim 38 inwhich said releasing of the lens is effected by moving the plunger in alongitudinal direction after the lens is moved out of said tubularmember.
 40. A method in accordance with claim 39 in which said moving ofthe lens to effect its release includes retracting said plunger intosaid tubular member so that the lens engages against the distal end ofsaid tubular member to cause release of the lens from said plunger. 41.A method in accordance with claim 36 in which the lens is held in saidtubular member in an unstressed state.
 42. A method in accordance withclaim 41 in which the lens is held in said tubular member such that itsoptic portion is suspended to avoid any substantial contact withinterior portions of said tubular member.
 43. A method of implanting aflexible membrane into an eye, said method comprising inserting a distalportion of a tubular member through an incision in an eye, holding aflexible membrane in said tubular member, engaging and holding saidflexible membrane with a distal tip of a plunger, moving said flexiblemembrane along a path defined in said tubular member, folding saidflexible membrane as it moves along said path so that the flexiblemembrane is compressed to a smaller size and moving said flexiblemembrane out of said tubular member and into the eye.
 44. A method inaccordance with claim 43 in which said moving of the flexible membranethrough said tubular member and into the eye is performed in onecontinuous motion after the tubular member is inserted through anincision in the eye.
 45. A method in accordance with claim 43 furthercomprising the steps of holding said flexible membrane to said distaltip of said plunger when the flexible membrane is moved out of saidtubular member, and releasing said flexible membrane from said plunger.46. A method in accordance with claim 45 in which said releasing of theflexible membrane is effected by moving the plunger in a longitudinaldirection after the flexible membrane is moved out of said tubularmember.
 47. A method in accordance with claim 46 in which said moving ofthe flexible membrane to effect its release includes retracting saidplunger into said tubular member so that the flexible membrane engagesagainst the distal end of said tubular member to cause release of theflexible membrane from said plunger.
 48. A method in accordance withclaim 43 in which the flexible membrane is held in said tubular memberin an unstressed state.
 49. A method in accordance with claim 48, inwhich the flexible membrane is held in said tubular member such that acentral portion thereof is suspended to avoid any substantial contactwith interior portions of said tubular member.
 50. A device forinserting a flexible membrane into an eye comprising: a tubular memberincluding a base member, a cover, and a cannula said tubular memberfurther including a passage for receiving a flexible membrane, saidpassage having an open distal end in said cannula for inserting theflexible membrane into an eye, said base member having a stage forsupporting the flexible membrane in an unstressed state, said coverbeing pivotally attached to said base member or said cannula formovement between an open position to permit access to the flexiblemembrane and a closed position to overlie said stage for insertion ofthe flexible membrane into an eye; and a plunger being movably receivedwithin said tubular member for moving the flexible membrane along saidpassage and into an eye.